Document Title | Research Applicability |
---|---|
Protocol and Informed Consent | |
Requirements for Protocol Documents | Applies to clinical trials |
Requirements for Informed Consent Development | Applies to human subjects research |
Clinical Site | |
Requirements for Human Subject Protection (HSP) and Good Clinical Practice (GCP) Training | The HSP requirement applies to all human subject research.
The HSP and GCP requirements apply to all clinical trials. |
Requirements for Source Documentation | Applies to clinical trials |
Requirements for Manual of Operational Procedures (MOP) | Applies to clinical trials |
Requirements for Clinical Quality Management Plans | Applies to clinical trials |
Requirements for On-site Monitoring | Applies to clinical trials |
Safety | |
Study Progress and Safety Monitoring | Applies to clinical trials |
Expedited Adverse Event Reporting | Applies to clinical trials |
Laboratories | |
Requirements for DAIDS Funded and/or Sponsored Laboratories | Applies to clinical trials |
Regulatory | |
Determination of Investigational New Drug Application (IND) | Applies to clinical trials |
Requirements for Essential Documents | Applies to clinical trials |
Protocol Registration | Applies to clinical trials and to observational studies conducted by the DAIDS-sponsored Clinical Trials Networks |
Pharmacy | |
Requirements for Pharmacy Facilities | Applies to clinical trials |
Requirements for Pharmacy Activities | Applies to clinical trials |
Requirements for Pharmacy Personnel | Applies to clinical trials |
Data Management and Statistics | |
Requirements for Data Management and Statistics | Applies to clinical trials |
Content last reviewed on December 21, 2006